This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). The study is investigating the effectiveness of a combination of two treatments: Niraparib and Pembrolizumab. Niraparib is a medication that is taken orally in tablet form, while Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the effects of these medications against a placebo, which is a substance with no active drug, to see if the combination can help maintain the stability of the disease or improve the response after initial chemotherapy treatment.
The purpose of the study is to determine if the combination of Niraparib and Pembrolizumab can help patients live longer without the disease getting worse, and to see if it can improve overall survival compared to the placebo. Participants in the study will have already received a first-line treatment with platinum-based chemotherapy and Pembrolizumab, and their disease should have either remained stable or shown improvement. The study will involve regular monitoring and assessments to track the progress of the disease and the effects of the treatment.
Throughout the study, participants will receive either the combination of Niraparib and Pembrolizumab or a placebo with Pembrolizumab. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The study will continue for a set period, during which participants will be closely monitored for any changes in their condition and any side effects they may experience. The ultimate goal is to find a more effective maintenance therapy for patients with advanced or metastatic NSCLC.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and ability to take oral medication.
Participants must have completed a certain number of chemotherapy cycles and show stable or improved disease status.
2treatment phase
Participants receive a combination of medications as maintenance therapy. This includes pembrolizumab, administered as an infusion, and either niraparib or a placebo, taken orally.
The dosage for pembrolizumab is 25 mg/mL, and it is given as a solution for infusion. The specific dosage and frequency for niraparib or placebo are determined by the study protocol.
3monitoring and assessments
Regular assessments are conducted to monitor the progression of the disease and overall health. This includes imaging tests and evaluations based on specific criteria.
Participants are observed for any side effects or adverse reactions to the medications.
4end of treatment
The treatment phase continues until the study’s end date or until specific criteria for discontinuation are met.
Participants may continue to be monitored for a period after the treatment phase to assess long-term effects and overall survival.
Who Can Join the Study?
Participants must be at least 18 years old. In Korea, participants must be at least 19 years old.
Participants who had side effects from their initial treatment must have recovered to a certain level of health, and there should be no severe ongoing side effects.
Participants must be able to swallow and keep the study medication in their system.
Female participants must not be pregnant or breastfeeding. They must either not be of childbearing potential or use a highly effective birth control method. They must also have a negative pregnancy test before starting the study.
Male participants must agree not to donate sperm and either abstain from sexual activity or use a condom during the study and for 90 days after the last dose.
Participants must understand the study procedures and agree to participate by signing a consent form.
Participants must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) without specific genetic changes that can be targeted by approved treatments.
Participants must have advanced or metastatic NSCLC, meaning the cancer has spread and cannot be treated with standard chemotherapy and radiation.
Participants must have completed 4 to 6 cycles of initial chemotherapy with pembrolizumab, a type of cancer treatment.
Participants must have stable disease, partial response, or complete response to their cancer treatment as assessed by their doctor.
Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
Participants must have a life expectancy of at least 12 weeks.
Participants must have adequate organ and bone marrow function, which includes specific levels of blood cells and liver function.
Participants must provide a sample of their tumor tissue, preferably collected after being diagnosed with advanced or metastatic NSCLC and before starting initial treatment.
Who Cannot Join the Study?
Patients with other types of cancer besides Non-Small Cell Lung Cancer cannot participate. This means if you have a different kind of cancer, you are not eligible.
Patients who are not within the specified age range for the study cannot participate. The study is looking for people in certain age groups.
Patients who are part of a vulnerable population, which means people who might need special protection or care, are not eligible for this study.
Patients who do not meet the specific health requirements set by the study cannot participate. This means if your health condition does not match what the study needs, you cannot join.
Niraparib is a medication used in this trial as part of a maintenance therapy. It is designed to help keep the cancer from growing or spreading after initial treatment. Niraparib works by interfering with the cancer cells’ ability to repair their DNA, which can lead to the death of these cells.
Pembrolizumab is an immunotherapy drug used in this trial. It helps the body’s immune system recognize and attack cancer cells. Pembrolizumab works by blocking a specific protein on the surface of immune cells, which can enhance the immune response against cancer cells.
Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. As it progresses, it may cause symptoms like persistent cough, chest pain, and shortness of breath. The progression of the disease can vary, with some tumors growing slowly and others more rapidly. Early detection is crucial for managing the disease effectively.
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